Yesterday US FDA has published a new guidance “M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use – Guidance for Industry”. FDA has addressed recommendations for eCTD 4.0. The guidance also provides separate tables describing the recommended granularity for paper and eCTD v3.2.2 submissions, and for paper and eCTD v4 submissions.
On March 15th 2016 the ISO IDMP task force meeting resulted in a staged approach on IDMP as well as suggested changes for iteration 1 data attributes and timelines. IDMP is mandatory in Europe since July 1st of 2016. By 2018 iteration 1 data attributes will need to be prepared for submission to the EMA. Read More
Recently, we were in a sales cycle for a regulatory software evaluation and received an interesting comment from the Managing Director of a medium sized approx. 100-employee originator pharmaceutical company. He said, „SaaS does not work for us, we prefer to have the software installed in house“. Read More
During many customer meetings we experienced a wow effect with a modern and light software user interface. But customer also challenged us, whether software that appears to be light and easy to use, can handle regulatory complexities. Let me share some thoughts about this: Read More
We all know the legislative deadline for submitting pharmacovigilance data as IDMP (Identification of Medicinal Products), is July 1st of 2016. We only have just a bit over a year time to become IDMP ready and prepare for the submission of medicinal product information. Read More